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Led by Nemours Children's Clinic · Updated on 2026-07-20
148
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to understand cardiovascular disease risk among adolescent girls aged 14 to 19 years with overweight or obesity. It compares an acceptance-based healthy lifestyle intervention to a health education program, focusing on weight loss and improvements in physiological, health-related, and psychological factors. The study is designed as a randomized controlled trial including diverse participants, with at least 40% from racial or ethnic minority groups. Participants are assigned to one of two groups an acceptance-based treatment ABT involving 18 group sessions of 90 minutes each over 6 months, delivered both in-person and remotely or a health education HE comparison group, receiving nine 75-minute group sessions with educational handouts over the same period. Both interventions are led by bachelors level paraprofessional coaches in a hybrid outpatient community clinic setting. During the 18-month study, participants complete assessments at baseline, 3, 6, 12, and 18 months. These include questionnaires, measurements of weight, height, body composition, blood pressure, and blood lipids, along with wearing smart watches to monitor sleep and physical activity. Researchers evaluate changes in BMI z-score at 6 months as the primary outcome, along with secondary outcomes related to adiposity, blood pressure, blood lipids, dietary intake, physical activity, and psychological wellbeing up to 18 months.
CONDITIONS
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
S
Stephanie Manasse, PhD
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Nemours Children's Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Acceptance-based Treatment (ABT) | Health Education (HE) Comparison |
|---|---|---|
| What it is | A structured behavioral program using acceptance-based approaches, psycho-education, and skills coaching to promote healthier eating, regular exercise, and weight loss in adolescents. | A behavioral intervention focused on delivering psycho-education and resources for healthy weight management without directive coaching; supports lifestyle changes via general health information. |
| Role in the trial | Investigational arm evaluating whether an acceptance-based behavioral program supports weight loss and improvements in lifestyle habits. | Active comparator group designed to match contact time and general educational content without directive techniques. |
| Primary use | Promoting sustainable weight loss and improving health-related behaviors in adolescent girls through acceptance and commitment-based behavioral methods. | Providing general knowledge, motivation, and resources to support healthy weight and lifestyle, without specialized behavioral techniques. |
| How it is given or performed | Program delivered through sessions with psycho-education, skills-building, and individualized coaching aimed at addressing thoughts and behaviors related to eating and activity. | Participants receive sessions focused on psycho-education and informational resources for weight management, without skills training or directive coaching. |
| Evidence status | Ongoing clinical trial; results for this population are not yet established. Previous studies in similar populations suggest that acceptance-based approaches can help improve health behaviors and weight outcomes. | Serves as a comparator in ongoing research; limited evidence exists for the effectiveness of general health education alone in sustained weight loss for this population. |
| Important limitations | Evidence is still emerging and long-term weight loss data in diverse adolescents are limited. Individual response can vary, and regular participation is needed for benefit. | Traditional health education interventions without behavioral skill-building may be less effective for sustained weight loss. Engagement and personal behavioral change may be limited. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants attend group sessions for 6 months, either acceptance-based treatment with 18 sessions or health education with 9 sessions, delivered in person or remotely.
Group sessions held both in-person and via video conferencing
Duration - 12 months
Participants complete assessments at 3, 6, 12, and 18 months to monitor weight, physiological measures, and psychological outcomes.
Several assessment visits over 12 months after treatment ends
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Faith A Newsome, Michelle I Cardel, Xiaofei Chi...
https://pubmed.ncbi.nlm.nih.gov/36394498/Cynthia L Ogden, Margaret D Carroll, Hannah G Lawman...
https://pubmed.ncbi.nlm.nih.gov/27272581/Stephanie M Manasse, Jannah R Moussaoui, Elizabeth W Lampe...
https://pubmed.ncbi.nlm.nih.gov/39019153/Nemours Children's Clinic
Lead Sponsor
